Status:
UNKNOWN
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
Lead Sponsor:
Aeon Astron Europe B.V.
Conditions:
Open-angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medi...
Detailed Description
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimi...
Eligibility Criteria
Inclusion
- Age 18 years or over
- Uncontrolled open-angle glaucoma
- Subject is willing to sign informed consent
- Subject is able and willing to complete post-operative follow-up requirements
Exclusion
- Inflammatory eye diseases
- Angle-closure glaucoma
- Secondary glaucoma with anatomical malformations of the eye
- Subjects having single functional eye
- Previous conjunctival surgery
- Known allergic reactions to ingredients of ologen Collagen Matrix
- Excessive myopia (axial length (AL)\> 27 mm or more than -10 diopters)
- Previous vitrectomy eye surgery
- Subjects do not consent to participate
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01174420
Start Date
November 1 2009
End Date
November 1 2011
Last Update
May 9 2011
Active Locations (1)
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1
The University Hospital of Cologne
Cologne, Germany, 50937